Transplant Trial Watch

Renal Protective Effect of Everolimus in Liver Transplantation: A Prospective Randomized Open-Label Trial.

Kadry, Z., et al.

Transplantation Direct 2021; 7(7): e709.

This study aimed to compare the renal protective effect of everolimus (EVR) versus standard calcineurin inhibitor (CNI)-based immunosuppression in liver transplant recipients.

Participants were randomly assigned to either the EVR arm or the standard of care (SOC) arm.

24 liver transplant recipients.

Primary outcome: renal function (assessed by 24-hour urine Cockcroft-Gault creatinine clearance (CrCl)). Secondary outcomes: CrCl, modification of diet in renal disease (MDRD), estimated glomerular filtration rate (eGFR), iothalamate clearance, 24-h urine protein, white blood cell count, absolute neutrophil count, and testosterone.

24 months

CET Conclusions
This is an RCT in liver transplantation examining the effect of using everolimus instead of CNI in terms of renal function. The study was small, with only 12 patients per arm, and a significant proportion (4/12) did not complete the follow up in the everolimus arm, one of whom had hepatic artery thrombosis (HAT). 105 patients were screened for the study and 93 were not suitable. Confusingly, the study was powered for a reduction in estimated GFR, but the primary outcome is described as difference in measured creatinine clearance with 24 hour urine sample. The results show a significantly improved serum creatinine and measured clearance at 24 months in the everolimus arm. However, this is based upon available data. The authors did make imputations for missing data and this is included in the supplemental digital content, showing similar outcomes. It is a highly selected population, and even then there were a concerning proportion of dropouts and with HAT in one case.

Jadad score

Data analysis
Strict intention-to-treat analysis

Allocation concealment

Trial registration
ClinicalTrials.Gov - NCT01936519

Funding source
Industry funded